Inclusion of Women in Clinical Trials During Drug Development

Policy Issue
From the Drugs Directorate

The Food and Drugs Act and Regulations require that, prior to conducting clinical trials in Canada, a drug manufacturer must file an investigational new drug submission with Health Canada. The role of the Drugs Directorate of the Department is to ensure that these trials do not pose undue risks to patient safety, and that there is a reasonable expectation that the trial will result in data that is appropriate and sufficient to support subsequent market authorization of the drug product.

The Drugs Directorate is reviewing its current regulatory guidelines to ensure the appropriate inclusion of women in clinical trials, and to address the need for suitable information on the effects of drugs in this population. As an underlying policy effective immediately, the Drugs Directorate will require the enrollment of a representative number of women into clinical trials for those drugs that are intended to be used specifically by women or in populations that are expected to include women. In general, clinical trials should be composed of representatives of the same segments of society as the manufacturer expects to use the drug after market approval or the manufacturer must present clear scientific reasons for not doing so. To implement this policy, current guidelines will be amended to :

• elaborate on information required when filing a submission for market approval and
  
• identify information requirements in labelling and Product Monographs
  
• define the need to enroll women of reproductive age in clinical trials, while ensuring that adequate information is provided to them on fetal toxicity and teratogenicity, thereby assisting them in making informed choices when choosing to participate in clinical trials.

As with all Drugs Directorate guidelines, a broad-based consultative process will be undertaken and will include health advocacy and women's groups, the Medical Research Council (MRC) and the research community, the health professions, and the pharmaceutical industry to ensure that the guidelines implementing this policy are clear and understood.

This policy is consistent with that taken by other regulatory agencies that have taken steps to encourage the study of all subpopulations in their countries.

1997-05-27